| View |
|
DRP-9009
|
Calamine + Zinc Oxide
|
Zinclamine
|
40mg/30mg per gram
|
Cream
|
Over-the-Counter (OTC)
|
White Double Wall Jar x 10g and 15g
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
|
|
|
-
|
03 August 2020
|
03 August 2025
|
| View |
|
DRP-9009-01
|
Calamine + Zinc Oxide
|
None
|
40 mg/ 30 mg per gram
|
Cream
|
Over-the-Counter (OTC)
|
White Double Wall Jar x 10g and 15g
|
-
|
Azarias Pharmaceutical Laboratories Inc,
|
Philippines
|
|
Eba Generisch Trading Inc.
|
Eba Generisch Trading Inc.
|
-
|
24 June 2021
|
03 August 2025
|
| View |
|
DRP-9009-02
|
Calamine + Zinc Oxide
|
Aliskati
|
40mg/ 30mg
|
Cream
|
Over-the-Counter (OTC)
|
White double wall jar x 10g and 15g
|
-
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
|
|
St. Raphael Archangel Pharmaceutical Product
Distribution
|
-
|
27 July 2021
|
03 August 2025
|
| View |
|
DRP-9009-03
|
Calamine + Zinc Oxide
|
None
|
40mg/ 30mg per gram
|
Cream
|
Over-the-Counter (OTC) Drug
|
White double wall jar x 10g and 15g
|
-
|
Azarias Pharmaceutical Laboratories Inc,
|
Philippines
|
|
|
Daily Grace Unlimited Inc.
|
-
|
15 November 2021
|
03 August 2025
|
| View |
|
DRP-9010
|
Multivitamins + Iron
|
Flexiron Plus
|
165mg (Equivalent to 500 mg Ferrous Fumarate)/2mg/ 230 mcg/3 mcg
|
Capsules
|
Over-the-Counter (OTC)
|
Alu/Alu Strip Pack x 10's (Box of 30's and 100's)
|
-
|
Kanion Pharmaceutical Co. Ltd.
|
China
|
N/A
|
AMB HK Enterprises Inc.
|
Vispomed Enterprises
|
Initial (OTC) (Revalidation)
|
11 August 2023
|
03 August 2025
|
| View |
|
DRP-9011
|
Thiamine Mononitrate (Vitamin B1)+ Pyridoxine
Hydrochloride (Vitamin B6) + (Vitamin B12)
|
Ambigen
|
100 mg/5 mg/50 mcg
|
Capsules
|
Over-the-Counter (OTC)
|
Alu/Alu Strip Pack x 10's (Box of 30's and 100's)
|
-
|
Kanion Pharmaceutical Co. Ltd.
|
China
|
N/A
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
Initial [OTC][Revalidation]
|
04 August 2023
|
03 August 2025
|
| View |
|
DRP-9012
|
Mometasone Furoate
|
Mfsone
|
1 mg/g (0.1% w/w)
|
Cream
|
Over-The-Counter (OTC)
|
Lami Tube packed in Printed Monocarton x 10 g
|
-
|
Scott-Edil Pharmacia Limited
|
India
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
Initial
|
03 August 2020
|
03 August 2025
|
| View |
|
DRP-9013
|
Fusidic Acid
|
Sudif
|
20 mg/g (2% w/w)
|
Cream
|
Over-the-Counter (OTC) Drug
|
Laminated Tube packed in Printed Monocarton x 10g
(Box of 1's)
|
-
|
KLM Laboratories Pvt. Ltd.
|
India
|
|
AMB HK Enterprises Inc.
|
FSPC Pharmaceuticals Inc.
|
Initial (Variation)
|
26 January 2024
|
03 August 2025
|
| View |
|
DRP-9014
|
Clotrimazole
|
Zycozole
|
10 mg/g (1% w/w)
|
Cream
|
Over-the-Counter (OTC) Drug
|
Lami Tube packed in Printed Monocarton x 15g (Box of 1's)
|
Antifungal (Imidazole)
|
KLM Laboratories Pvt. Ltd.
|
India
|
|
AMB HK Enterprises Inc.
|
FSPC Pharmaceuticals Inc.
|
Initial (Variation) Correction
|
19 June 2024
|
03 August 2025
|
| View |
|
DRP-9021
|
Multivitamins + Iron
|
Siderfol
|
see formulation on reverse side
|
Capsule
|
Over-the-Counter (OTC)
|
Blister Strip x 10's (Box of 100's)
|
-
|
Spectrum Pharmaceuticals Pvt. Ltd.
|
India
|
|
Raptakos Brett & Co., Ltd
|
Raptakos Brett & Co., Ltd
|
PCPR
|
04 August 2020
|
01 April 2025
|
| View |
|
DRP-9024
|
Cetirizine Dihydrochloride
|
Virilex
|
10 mg
|
Film-Coated Tablet
|
Over-the-Counter (OTC)
|
Alu/PVC Blister Pack x 10's (Box of 100's)
|
-
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
-
|
04 August 2020
|
04 August 2025
|
| View |
|
DRP-9024-01
|
Cetirizine dihydrochloride
|
Erilife
|
10 mg
|
Film-Coated Tablet
|
Over-the-Counter (OTC) Drug
|
Alu/PVC Blister Pack x 10's / (Box of 100's)
|
Antihistamine
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
|
AMB HK Enterprises Inc
|
Life and Health Source Pharmaceutical Distribution Co.
|
CLIDP Conversion
|
18 June 2024
|
04 August 2025
|
| View |
|
DRP-9025
|
Calcium + Cholecalciferol
|
Caltone
|
500 mg (Equivalent to 1.25 g Calcium Carbonate) / 200 IU
|
Tablet
|
Over-the-Counter (OTC)
|
PET/Alu/PE Blister Pack x 4's (Box of 32's)
|
-
|
Kanion Pharmaceutical Co. Ltd.
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
-
|
04 August 2020
|
04 August 2025
|
| View |
|
DRP-9026
|
Calcium + Cholecalciferol
|
Ambical-Plus
|
500mg (Equivalent to 1.25 g Calcium carbonate)/200 IU
|
Tablet
|
Over-the-Counter (OTC)
|
PET/Alu/PE Blister Pack x 4's (Box of 32's)
|
-
|
Kanion Pharmaceutical Co. Ltd.
|
China
|
|
AMB HK Enterprises Inc.
|
AMB HK Enterprises Inc.
|
-
|
04 August 2020
|
04 August 2025
|
| View |
|
DRP-9027
|
Hydroquinone
|
Blanc White
|
40 mg/g (4% w/ w)
|
Cream
|
Over-The-Counter (OTC)
|
PET Bottle x 15 g with PP Nozzle and PP Cap (Box of 1's)
|
Anti-hyperpigmentation
|
Stalder Laboratories
|
Philippines
|
BPC Dermatological Corp.
|
|
|
Automatic Renewal
|
15 March 2023
|
19 April 2028
|
| View |
|
DRP-9028
|
Fusidic Acid
|
Sidik
|
20 mg/g (2% w/w)
|
Cream
|
Over-the-Counter (OTC)
|
Laminated Tube x 15 g (Box of 1's)
|
-
|
Rhydburg Pharmaceuticals Limited
|
India
|
|
Aglobal Care, Inc.
|
Aglobal Care, Inc.
|
-
|
04 August 2020
|
04 August 2025
|
| View |
|
DRP-9029
|
Rosuvastatin (as Calcium)
|
Rosufar-20
|
20mg
|
Film-Coated Tablet
|
Prescription Drug (Rx)
|
Alu/Alu Blister Pack of 3's x 10 Tablets (Box of 30's)
|
-
|
ZIM LABORATORIES LIMITED
|
India
|
|
Pharmkon Biotec Inc.
|
Pharmkon Biotec Inc.
|
-
|
18 August 2020
|
18 August 2025
|
| View |
|
DRP-9029-01
|
Rosuvastatin (as Calcium)
|
Astadix 20
|
20 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
-
|
Zim Laboratories Limited
|
India
|
ZIM LABORATORIES, LTD.
|
Pharmakon Biotec, Inc.
|
Teramedix Pharma Trading, Inc.
|
-
|
01 October 2021
|
18 August 2025
|
| View |
|
DRP-9029-02
|
Rosuvastatin (As Calcium)
|
Rosipid
|
20 mg
|
Film-Coated Tablet
|
Prescription Drug (RX)
|
Alu/Alu Blister Pack x 10's (Box of 30's)
|
Lipid Modifying Agent (HMG COA reductase inhibitor)
|
Zim Laboratories, Ltd.
|
India
|
N/A
|
Pharmakon Biotec Inc.
|
228 Pharma Trading
|
CLIDP
|
21 January 2022
|
18 August 2025
|
| View |
|
DRP-9030
|
Isosorbide-5-Mononitrate
|
Acunasyn
|
20mg
|
Tablet
|
Prescription Drug (RX)
|
Alu/ Clear PVC Blister pack x 10's (Box of 100's)
|
-
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
|
|
|
-
|
17 August 2020
|
17 August 2025
|